Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis

A Phase 3 Study to Demonstrate the Safety and Efficacy of Recombinant Platelet-Activating Factor Acetylhydrolase (rPAF-AH, Pafase®) for Reducing 28 Day All Cause Mortality in Patients With Severe Sepsis

The objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all cause mortality in patients with severe sepsis.

This study is a randomized, double-blind, placebo-controlled, multicenter study of rPAF-AH compared to placebo in patients with severe sepsis. Eligible patients from investigative sites located throughout the United States and other countries will be randomized to receive either rPAF-AH or placebo administered daily for five consecutive days by intravenous (IV) infusion. All patients will be evaluated for safety and efficacy endpoints over 28 days. A follow-up evaluation will occur approximately 6 months after Day 28 to assess functional status and quality of life.

Inclusion criteria

• Clinical diagnosis of severe sepsis
• At least 18 years old
• Patient or legally authorized representative able to provide informed consent

Exclusion criteria

• Severe lung injury (acute respiratory distress syndrome)
• Immunocompromised
• Severe liver disease
• Inflammation of the pancreas, organ rejection, or burns to more than 30% of body
• Enrolled in another clinical trial
• Already participated in this or other rPAF-AH study
• There is not a commitment to aggressive treatment
• Has a disease with life expectancy less than 6 months